Alere™ i Influenza A & B

FDA UDI

Class II (US FDA UDI)

by Alere Scarborough, Inc.

Identity

Trade Name: Alere™ i Influenza A & B FDA UDI
Generic Name: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name: A rapid, automated, molecular test for the qualitative detection of inuenza A and B viral nucleic acid in respiratory specimens. FDA UDI
Model / Reference: 425-024 FDA UDI
Description: A rapid, automated, molecular test for the qualitative detection of inuenza A and B viral nucleic acid in respiratory specimens. FDA UDI

Identifiers

Primary DI / UDI-DI: 10811877010804 FDA UDI
510(k) Number: K141520 FDA UDI
FDA Product Code: OCC FDA UDI
OZE FDA UDI
OOI FDA UDI
GMDN Term: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3980 FDA UDI
862.2570 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Alere™ i Influenza A & B by Alere Scarborough, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K141520 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Alere Scarborough, Inc.

Sources (1)

FDA UDI b331a89b-0b33-4379-842e-39f72d140095 35 fields · synced Jun 1, 2026